The Training Coordinator for Drug Product Finished Goods needs to develop, implement, and oversee training programs for personnel involved in drug product manufacturing, filling, inspection, and packaging operations to ensure compliance with cGMP regulations, enhance operational efficiency, and support continuous improvement initiatives within sterile and non-sterile finished goods production.
Requirements
- 2-5 years in training coordination or instructional design
- Experience developing and delivering technical training programs
- Experience with learning management systems
Responsibilities
- Designs and implements training programs for drug product manufacturing, including formulation, aseptic filling, visual inspection, and packaging
- Develops and maintains training materials such as standard operating procedures (SOPs), work instructions (WIs), and e-learnings
- Conducts classroom and hands-on training sessions for operators, technicians, and support staff
- Assesses and qualifies employees through written exams, practical demonstrations, and hands-on evaluations
- Supports aseptic process simulations and interventions for personnel qualification
- Conducts retraining and refresher courses as needed to address deviations or regulatory change
- Monitors production floor activities to ensure adherence to trained procedures and identifies areas for improvement
Other
- High School Diploma/GED and 4 years direct experience OR Associate degree in life sciences with 2 years of direct experience OR Bachelors in life sciences or education with no experience OR Equivalent military training/experience
- Ability to sit for prolonged periods of time
- Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers
